Can You Get Cervical Cancer Again
, by NCI Staff
Dual-stain testing on Pap test samples identifies the presence of 2 proteins: p16 (chocolate-brown) and Ki-67 (cherry).
Credit: National Cancer Establish
UPDATE: On March 11, 2020, the Food and Drug Administration (FDA) canonical the first dual-stain test for women who have tested positive for HPV. The test, called CINtec® PLUS Cytology, is used to help doctors decide if an HPV-positive woman should have a biopsy to await for cervical precancer or cancer.
A new exam, called dual stain, may help improve how doctors care for women who test positive for human papillomavirus (HPV) infection during routine cervical cancer screening, an NCI-led study has shown. HPV tests discover infections with the cancer-causing types of HPV.
For most women, HPV infections go away on their own. But for some, the infection leads to precancerous growths that can progress to cervical cancer. To better treat women who are HPV positive, researchers have been exploring ways to help tell whether an HPV infection is likely to cause precancer.
Equally HPV testing becomes a more mutual method of cervical cancer screening, "the challenge is how to best manage, or triage, HPV-positive women," said the study'southward senior investigator, Nicolas Wentzensen, Thousand.D., Ph.D., of NCI's Division of Cancer Epidemiology and Genetics (DCEG).
Doctors usually use a Pap exam, also called a Pap smear, to determine whether an HPV infection is likely to cause precancer and help decide whether a woman should get a biopsy. Merely, according to the NCI written report, the dual-stain exam was better than the Pap test at predicting whether HPV-positive women adult cervical precancer inside 5 years.
The findings suggest that HPV-positive women with a positive dual-stain examination result should get a biopsy to check for cervical precancer or cancer, the study authors concluded, whereas those with a negative result tin can safely wait iii years before getting screened once again. Results from the prospective study were reported October 11 in JAMA Oncology.
"This is a very important study," said Mark Stoler, Grand.D., acquaintance director of Surgical Pathology and Cytopathology at the Academy of Virginia Schoolhouse of Medicine. It's the beginning written report performed in the United States, Dr. Stoler continued, "that actually provides the assurance that [dual stain] is a meliorate triage test" than the Pap test.
Cervical Cancer Screening in the United States
There are around 12 different types of HPV that can cause cervical and other types of cancer. HPV infections that aren't controlled by the immune system are the cause of nearly all cervical cancers. Cervical cancer screening tests look for disease in people who take no symptoms.
Current United states of america guidelines for cervical cancer screening recommend i of iii approaches: an HPV test alone, a combination of HPV and Pap tests (an HPV/Pap cotest), or a Pap test alone.
According to the US Preventive Services Task Force, women age 30 to 65 years at average risk of cervical cancer tin be safely screened with an HPV examination or HPV/Pap cotest every v years.
Although HPV/Pap cotesting has improved the accuracy of cervical cancer screening and helped to greatly reduce the incidence of cervical cancer, it has some limitations.
For example, some women who test positive for HPV and who take minor abnormalities on a Pap test are referred for colposcopy, a process in which biopsies are taken of aberrant areas in the cervix (visit NCI's page on cervical screening tests for the most upwardly-to-date recommendations).
Merely merely a small pct of Pap exam abnormalities plough out to be cervical precancer or cancer, meaning most of these women had an unnecessary colposcopy, Dr. Wentzensen explained. Because of these limitations, "there is a big effort to find better markers that let us to triage HPV-positive women more efficiently," he said.
In terms of potential triage approaches for HPV-positive women, dual-stain testing "is probably the most avant-garde method available," said the study's lead investigator, Megan Clarke, Ph.D., M.H.S., too of DCEG. The new study adds to that body of evidence, she said.
The dual-stain arroyo has been nether study for more than a decade, Dr. Stoler said. Information technology measures the presence of ii specific proteins, p16 and Ki-67, in a sample of cervical cells. The expression of p16 is strongly linked with HPV infection, and Ki-67 is used as a biomarker for the rapid cell sectionalization seen in precancers and cancer.
Previous studies have provided some prove that dual-stain testing is better at identifying HPV-positive women who have precancers than Pap testing, just none followed patients forwards in time for more than 3 years.
Searching for a Ameliorate Triage Exam for HPV-Positive Women
To conduct this new report, the investigators followed 1,549 women aged 30 or older who had tested positive for HPV (on a exam that gives combined results for 13 cancer-causing types) while undergoing routine HPV/Pap cotesting at Kaiser Permanente Northern California between January and May 2012. Dual-stain testing was performed on participants' cervical cell samples at the beginning of the written report.
Women with a normal Pap examination result were advised to echo the cotest in 1 year, whereas women with an abnormal result were referred for immediate colposcopy and biopsy. Biopsy results can reveal a range of disease states, including normal, low-grade to loftier-class precancer, and cancer.
Overall, 46% of women in the study had a positive dual-stain examination result and 51% had an abnormal Pap exam result. More than women with severely aberrant Pap test results than women with normal Pap results had a positive dual-stain test outcome. Over the v-year study period, 77% of women found to have a loftier-grade precancer and 91% found to have cancer had a positive dual-stain exam effect.
Compared with Pap examination results, dual-stain test results were far more indicative of the 5-yr take a chance of cervical precancer, the team found. For example, women with a positive dual-stain test result had a college take chances of developing cervical precancer over the side by side 5 years than women with a positive Pap test effect.
Conversely, women with a negative dual-stain exam result had a lower risk of developing cervical precancer within 5 years, compared with women with a normal Pap exam result.
This means that a negative dual-stain test effect gives greater reassurance than a normal Pap test outcome that precancer won't develop during the ensuing v years, Dr. Wentzensen explained.
Dr. Clarke said that the study also addressed a critical question: "How often and at what time interval should HPV-positive women who test negative with dual stain come back for repeat screening?"
Based on the 5-year risks of cervical precancer, the researchers determined that HPV-positive women with a negative dual-stain issue can safely expect 3 years before being screened again.
Together, the findings propose that using the dual-stain examination to triage HPV-positive women might lead to fewer unnecessary colposcopies, Dr. Clarke noted.
The higher sensitivity (i.due east., better at identifying women with a higher chance of having precancer) and specificity (i.east., improve at identifying those with a low risk) of the dual stain-test compared with the Pap test is impressive, Dr. Stoler said.
"Information technology's very difficult to have a exam that improves sensitivity and specificity, but dual stain does information technology because of the biology behind the development of the examination," he explained.
Learning More About Dual Stain
The dual-stain test is already being marketed and used in several countries, including Canada, Europe, and Australia, Dr. Stoler said. The clinical trial that would form the ground of FDA clearance for the dual-stain test in the United States is currently ongoing, he added.
In the hereafter, HPV testing followed by dual stain for primary cervical cancer screening may be a more efficient alternative to HPV/Pap cotesting, Drs. Wentzensen and Clarke said.
The manufacturer of the dual-stain test is analyzing the development of cervical precancer in HPV-positive women who have a positive test upshot from either dual stain or Pap in an ongoing report. In addition, Dr. Wentzensen and his colleagues are investigating the results of dual stain testing in a big population of women, including many who are HPV negative.
"I retrieve there will be sufficient information to change practice based on these observational studies," said Dr. Wentzensen.
And the test may soon have other attractive qualities, the investigators noted. A major reward of the dual-stain examination, said Dr. Wentzensen, is that aberrant cells are highlighted with a colored stain and are therefore easier to detect and quantify than cells stained for a Pap test.
"Currently, the dual-stain test is evaluated manually, but we are working on an automated evaluation of this analysis and we have exciting results," he added. Automation of the dual-stain examination would enhance its reliability and make it easier to use, he said.
Source: https://www.cancer.gov/news-events/cancer-currents-blog/2018/dual-stain-test-cervical-hpv-positive
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